Diabetes Mellitus, Type 2Phase 2NCT01241448
A Study of LY2409021 in Patients With Type 2 Diabetes
A Phase 2 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 40 sites in 7 countries.
Trial summary
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2409021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 40 sitesin 7 countries
- Study dates
- Jan 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
- Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
- Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 milligram per day (mg/day).
- Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
- Have a body mass index (BMI) between 25 to 45 kilogram per meter squared (kg/m^2), inclusive.
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- In the opinion of the investigator, are capable and willing to:
- Perform self-monitoring of blood glucose
- Complete a study diary as required for this protocol
- Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
- Comply with treatment regimens
- Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
Who cannot join
- Have more than 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
- Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
- Have had a previous diagnosis of pancreatitis.
- Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
- Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
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- Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
- Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
- Have poorly controlled hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) as determined by the mean of three separate measurements.
- Show evidence of labile blood pressure, including symptomatic postural hypotension.
- Have any abnormality of the ECG that would impact patient safety or data interpretation.
- Show clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
- Have a current or previous diagnosis of Gilbert's disease.
- Have previous or current diagnosis of Hepatitis B or C
- Have a serum creatinine >2 milligrams per deciliter (mg/dL) or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
- Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening; patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
- Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1c (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
- Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a personal or family history of pancreatic neoplasia.
- Have non-fasting triglycerides >600 mg/dL.
- Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
- Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
- Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations) or have received such therapy within 8 weeks prior to screening.
- Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility, central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin greater than or equal to 1 grams per day (gm/day).
- Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 milliliters (mL) of wine; 1.5 oz or 45 milliliter (mL) of distilled spirits).
- Currently use drugs with a narrow therapeutic index (for example, digoxin, lithium, phenytoin, theophylline, and warfarin).
- Currently use drugs that are known to prolong the QT interval.
- Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
- Have previously completed or withdrawn from this study or any other study investigating LY2409021.
- Have known allergies to LY2409021 or related compounds.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
United States18 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Burbank, California, 91505
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Charlotte, North Carolina, 28209
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Concord, California, 94520
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Fargo, North Dakota, 58103
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Fresno, California, 93720
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Henderson, Nevada, 89052
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Idaho Falls, Idaho, 83404
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Lakewood, California, 990712
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Los Angeles, California, 90057
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Meridian, Idaho, 83646
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Mission Hills, California, 91345
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Palm Springs, California, 92262
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Raleigh, North Carolina, 27609
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Roseville, California, 95661
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San Luis Obispo, California, 93401
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St Louis, Missouri, 63141
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Topeka, Kansas, 66606
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Wilmington, North Carolina, 28401
Germany7 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Damme, 49401
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Dresden, 01307
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Elsterwerda, 04910
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Hohenmölsen, 06679
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Lüneburg, 21339
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Ludwigshafen, 67059
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Mainz, 55116
Romania5 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baia Mare, 430123
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Brasov, 500365
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Bucharest, 050538
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Iași, 700547
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Târgu Mureş, 540098
Puerto Rico3 sites
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Hato Rey, 00917
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Manati, 00674
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San Juan, 00917-3104
Spain3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alicante, 03114
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Alzira, 46600
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Seville, 41003
Italy2 sites
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Chieti Scalo, 66013
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Milan, 20162
Slovakia2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Košice, 04012
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Malacky, 90101
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2409021, Placebo
- Keywords
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2409021Drug
Administered Orally
PlaceboDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. Receives: Drug: Placebo |
| 2.5 mg LY2409021 | Experimental | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. Receives: Drug: LY2409021 |
| 10 mg LY2409021 | Experimental | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. Receives: Drug: LY2409021 |
| 20 mg LY2409021 | Experimental | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. Receives: Drug: LY2409021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Secondary outcomes (15)
Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
SMBG profiles consisted of blood glucose values collected before and 2 hours after the 3 main meals and at 0300 hours (3:00 AM). Values represent mean of values collected same time on 3 separate days within a week prior to visit. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Plasma Glucose
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Insulin
Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total
GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. Total GLP-1 is the active GLP-1 and the Dipeptidyl Peptidase IV cleaved GLP-1 form. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
Fasting Lipid Profile included: Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)
Subfraction included: Very Low Density Lipoprotein (VLDL) Total. Least squares mean use an analysis of covariance model. The model included baseline lipoprotein subfractions, metformin use and treatment.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Free Fatty Acids
Least squares mean use an analysis of covariance model. The model included baseline free fatty acid, metformin use and treatment.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a computer model (based on HOMA2) which uses fasting plasma insulin and glucose concentrations to estimate insulin resistance (HOMA-IR) as a proportion reference population (normal young adults). The normal reference population with normal function was indexed to 1.0. Higher values indicate increased insulin resistance. Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B
HOMA-B is a computer model (based on HOMA-2) that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Higher values indicate greater beta cell function. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, 24 week
Change From Baseline to 24 Week Endpoint in Weight
Least squares means were adjusted for baseline weight, metformin use, visit, treatment and visit by treatment interaction.
Measured: Baseline, 24 weeks
Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021
Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Measured: Baseline up to 26 weeks
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Measured: Baseline up to 26 weeks
The Percentage of Participants Experiencing a Hypoglycemic Episode
A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)].
Measured: Baseline through 24 weeks
The 30-Day Adjusted Rate of Hypoglycemic Episodes
A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)]. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Outcome measure was not analyzed due to the limited number of hypoglycemic events observed.
Measured: Baseline through 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-4559) or 1-317-615-4559 Mon - Fri 9 Am - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241448
- Sponsor's protocol ID
- 13031
- Other IDs
- I1R-MC-GLBG
- Status last verified
- Mar 2018
- First submitted
- 12 Nov 2010
- Last updated
- 24 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tan AYF, Schneck K, Garhyan P, Chan ECY, Tham LS. Evaluation of Four Semi-Mechanistic Models for Predicting Glycemic Control With a Glucagon Receptor Antagonist in People With Type 2 Diabetes. CPT Pharmacometrics Syst Pharmacol. 2025 Aug;14(8):1381-1390. doi: 10.1002/psp4.70058. Epub 2025 Jun 17.
PubMed 40526184Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.
PubMed 26681715
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01241448
- Acronym / sponsor ID
- 13031
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 24 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTaken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 2.5 mg LY2409021 | Experimental | Drug: LY2409021Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 10 mg LY2409021 | Experimental | Drug: LY2409021Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 20 mg LY2409021 | Experimental | Drug: LY2409021Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
- Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
- Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 milligram per day (mg/day).
- Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
Key exclusion criteria (32 listed)
- Have more than 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
- Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
- Have had a previous diagnosis of pancreatitis.
- Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2409021Administered Orally | Drug | 10 mg LY2409021, 2.5 mg LY2409021, 20 mg LY2409021 |
| PlaceboAdministered Orally | Drug | Placebo |
Primary outcome
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 24 weeks
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
15 secondary outcomes
Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Plasma Glucose
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Insulin
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Free Fatty Acids
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B
Time frame: Baseline, 24 week
Change From Baseline to 24 Week Endpoint in Weight
Time frame: Baseline, 24 weeks
Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021
Time frame: Baseline up to 26 weeks
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
Time frame: Baseline up to 26 weeks
The Percentage of Participants Experiencing a Hypoglycemic Episode
Time frame: Baseline through 24 weeks
The 30-Day Adjusted Rate of Hypoglycemic Episodes
Time frame: Baseline through 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40526184Tan AYF, Schneck K, Garhyan P, Chan ECY, Tham LS. Evaluation of Four Semi-Mechanistic Models for Predicting Glycemic Control With a Glucagon Receptor Antagonist in People With Type 2 Diabetes. CPT Pharmacometrics Syst Pharmacol. 2025 Aug;14(8):1381-1390. doi: 10.1002/psp4.70058. Epub 2025 Jun 17.
- Derived from this study: PubMed 26681715Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-4559) or 1-317-615-4559 Mon - Fri 9 Am - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 40 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Romania, Puerto Rico, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.